- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01004640
Undersøgelse af blod- og knoglemarvsprøver hos patienter med kronisk myelogen leukæmi indskrevet i et CALGB klinisk forsøg
Molekylær og cytogenetisk overvågning af CML - en obligatorisk ledsager til CALGB 19804
RATIONALE: At studere prøver af blod og knoglemarv fra patienter med kræft kan hjælpe læger med at identificere biomarkører relateret til kræft.
FORMÅL: Denne forskningsundersøgelse ser på blod- og knoglemarvsprøver hos patienter med kronisk myelogen leukæmi, der er tilmeldt et CALGB klinisk forsøg.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
MÅL:
- Overvåg molekylære responsrater hos patienter, der modtager behandling for kronisk myelogen leukæmi ved kvantitativ revers transkriptionspolymerasekædereaktion (RT-PCR) og kvantitativ Southern blot-overvågning af blodprøver.
- Sammenlign kvantitative RT-PCR- og kvantitative Southern blot-resultater med marvcytogenetik på tidspunktet for fuldstændig molekylær respons hos disse patienter.
- Overvåg hyppigheden af resterende sygdom hos patienter, som opnår et fuldstændigt Southern blot og marv cytogenetisk blodrespons (udryddelse af BCR/ABL ved Southern blot og fravær af Philadelphia-kromosomet ved cytogenetik).
OVERSIGT: Perifere blodprøver og knoglemarvsaspirater udtages ved baseline og 3, 6 og 9 måneder efter start af behandlingen. Hvis patienten fortsætter med at modtage protokolbehandling efter 9 måneder, udtages yderligere perifere blodprøver hver 6. måned, og knoglemarvsaspirater tages årligt. I tilfælde af sygdomsprogression (blastkrise) udtages en ekstra perifer blodprøve og knoglemarvsaspirat.
Prøver undersøges ved kvantitativ Southern blot-analyse med prober til BCR, kvantitativ revers transkriptase-polymerase-kædereaktionsanalyse for BCR/ABL-fusionstranskripter og cytogenetisk analyse.
PROJEKTERET TILSLUTNING: I alt 60 patienter vil blive akkumuleret til denne undersøgelse inden for 1,5 år.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
-
-
California
-
San Diego, California, Forenede Stater, 92134
- Naval Medical Center - San Diego
-
San Francisco, California, Forenede Stater, 94115
- UCSF Medical Center-Mount Zion
-
-
Delaware
-
Lewes, Delaware, Forenede Stater, 19958
- Beebe Medical Center
-
Newark, Delaware, Forenede Stater, 19718
- Christiana Care Health Services
-
Seaford, Delaware, Forenede Stater, 19973
- Nanticoke Memorial Hospital
-
Wilmington, Delaware, Forenede Stater, 19805
- Saint Francis Hospital - Wilmington
-
-
District of Columbia
-
Washington, District of Columbia, Forenede Stater, 20010
- Washington Hospital Center
-
Washington, District of Columbia, Forenede Stater, 20057
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
-
-
Florida
-
Fort Lauderdale, Florida, Forenede Stater, 33316
- Broward Health Medical Center
-
Fort Lauderdale, Florida, Forenede Stater, 33308
- Holy Cross Hospital
-
Hollywood, Florida, Forenede Stater, 33021
- Memorial Healthcare System - Joe DiMaggio Children's Hospital
-
Jupiter, Florida, Forenede Stater, 33548
- Jupiter Medical Center
-
Miami Beach, Florida, Forenede Stater, 33140
- Mount Sinai Medical Center
-
-
Illinois
-
Bloomington, Illinois, Forenede Stater, 61701
- Saint Joseph Medical Center
-
Bloomington, Illinois, Forenede Stater, 61701
- Illinois CancerCare-Bloomington
-
Canton, Illinois, Forenede Stater, 61520
- Illinois CancerCare-Canton
-
Canton, Illinois, Forenede Stater, 29605
- Graham Hospital Assocation
-
Carthage, Illinois, Forenede Stater, 62321
- Illinois CancerCare-Carthage
-
Carthage, Illinois, Forenede Stater, 62321
- Memorial Hospital
-
Chicago, Illinois, Forenede Stater, 60637-1470
- University of Chicago Cancer Research Center
-
Chicago, Illinois, Forenede Stater, 60612-7243
- University of Illinois Cancer Center
-
Chicago, Illinois, Forenede Stater, 60608
- Mount Sinai Hospital Medical Center
-
Chicago, Illinois, Forenede Stater, 60640
- Weiss Memorial Hospital
-
Chicago, Illinois, Forenede Stater, 60612
- Jesse Brown Veterans Affairs Medical Center
-
Eureka, Illinois, Forenede Stater, 61530
- Eureka Hospital
-
Eureka, Illinois, Forenede Stater, 615330
- Illinois CancerCare-Eureka
-
Galesburg, Illinois, Forenede Stater, 61401
- Western Illinois Cancer Treatment Center
-
Galesburg, Illinois, Forenede Stater, 61401
- Galesburg Cottage Hospital
-
Galesburg, Illinois, Forenede Stater, 61401
- Illinois CancerCare Galesburg
-
Galesburg, Illinois, Forenede Stater, 61761
- Illinois CancerCare-Cottage
-
Granite City, Illinois, Forenede Stater, 62040
- Illinois Oncology Limited
-
Havana, Illinois, Forenede Stater, 62644
- Mason District Hospital
-
Havana, Illinois, Forenede Stater, 62644
- Illinois CancerCare-Havana
-
Hopedale, Illinois, Forenede Stater, 61847
- Hopedale Medical Complex - Hospital, Hopedale
-
Kewanee, Illinois, Forenede Stater, 61443
- Illinois CancerCare-Kewanee Clinic
-
Kewanee, Illinois, Forenede Stater, 61443
- Kewanee Hospital
-
Macomb, Illinois, Forenede Stater, 61455
- Illinois CancerCare-Macomb
-
Macomb, Illinois, Forenede Stater, 61455
- Mcdonough District Hospital
-
Monmouth, Illinois, Forenede Stater, 61462
- Illinois CancerCare-Monmouth
-
Monmouth, Illinois, Forenede Stater, 61462
- Holy Family Medical Center
-
Normal, Illinois, Forenede Stater, 61761
- Community Cancer Center Foundation
-
Normal, Illinois, Forenede Stater, 61761
- Illinois CancerCare-Community Cancer Center
-
Normal, Illinois, Forenede Stater, 61861
- Bromenn Regional Medical Center
-
Ottawa, Illinois, Forenede Stater, 61350
- Illinois CancerCare- Ottawa Clinic
-
Ottawa, Illinois, Forenede Stater, 61350
- Ottwa Regional Hospital and Healthcare
-
Pekin, Illinois, Forenede Stater, 61554
- Pekin Cancer Treatment Center
-
Pekin, Illinois, Forenede Stater, 61554
- Pekin Hospital
-
Pekin, Illinois, Forenede Stater, 61554
- Illinois CancerCare- Pekin
-
Peoria, Illinois, Forenede Stater, 61637
- OSF Saint Francis Medical Center
-
Peoria, Illinois, Forenede Stater, 61614
- Proctor Hospital
-
Peoria, Illinois, Forenede Stater, 61603
- Methodist Medical Center of Illinois
-
Peoria, Illinois, Forenede Stater, 61615
- Illinois CancerCare- Peoria
-
Peoria, Illinois, Forenede Stater, 61615
- Illinois Oncology Research Association-CCOP
-
Peru, Illinois, Forenede Stater, 61354
- Valley Radiation Oncology
-
Peru, Illinois, Forenede Stater, 61354
- Illinois Valley Hospital
-
Peru, Illinois, Forenede Stater, 61354
- Illinois CancerCare- Peru
-
Princeton, Illinois, Forenede Stater, 61356
- Perry Memorial Hospital
-
Princeton, Illinois, Forenede Stater, 61356
- Illinois CancerCare- Princeton
-
Rushville, Illinois, Forenede Stater, 62681
- Sarah Culberston Memorial Hospital
-
Spring Valley, Illinois, Forenede Stater, 61362
- Saint Margaret's Hospital
-
Spring Valley, Illinois, Forenede Stater, 61362
- Illinois CancerCare- Spring Valley
-
-
Indiana
-
Elkhart, Indiana, Forenede Stater, 46515
- Elkhart General Hospital
-
Fort Wayne, Indiana, Forenede Stater, 46845
- Fort Wayne Medical Oncology and Hematology
-
Kokomo, Indiana, Forenede Stater, 46904
- Community Howard Regional Health
-
La Porte, Indiana, Forenede Stater, 46350
- IU Health La Porte Hospital
-
Mishawaka, Indiana, Forenede Stater, 46545-1470
- Saint Joseph Regional Medical Center - Mishawaka
-
South Bend, Indiana, Forenede Stater, 46601
- Memorial Hospital of South Bend
-
South Bend, Indiana, Forenede Stater, 46628
- Northern Indiana Cancer Research Consrtium
-
-
Iowa
-
Cedar Rapids, Iowa, Forenede Stater, 52403
- Mercy Hospital
-
Cedar Rapids, Iowa, Forenede Stater, 52402
- Physicians' Clinic of Iowa PC
-
Cedar Rapids, Iowa, Forenede Stater, 54202
- Saint Luke's Hospital
-
Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa Hospitals and Clinics
-
Iowa City, Iowa, Forenede Stater, 52242-1002
- Holden Comprehensive Cancer Center at University of Iowa
-
-
Maine
-
Bangor, Maine, Forenede Stater, 04401
- CancerCare of Maine at Eastern Maine Medical Center
-
Bangor, Maine, Forenede Stater, 04401
- Eastern Maine Medical Center, Bangor
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21201
- University of Maryland/Greenebaum Cancer Center
-
Baltimore, Maryland, Forenede Stater, 21201
- Greenebaum Cancer Center at University of Maryland Medical Center
-
Elkton, Maryland, Forenede Stater, 21921
- Union Hospital Cancer Program at Union Hospital
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02215
- Beth Israel Deaconess Medical Center
-
Boston, Massachusetts, Forenede Stater, 02115
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, Forenede Stater, 02115
- Brigham and Women's Hospital
-
Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
-
Worcester, Massachusetts, Forenede Stater, 01655
- University of Massachusetts Medical School
-
Worcester, Massachusetts, Forenede Stater, 01605
- Commonwealth Hematology Oncology PC-Worcester, Worcester
-
-
Michigan
-
Saint Joseph, Michigan, Forenede Stater, 49085
- Oncology Care Associates PLLC
-
-
Missouri
-
Columbia, Missouri, Forenede Stater, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
-
Columbia, Missouri, Forenede Stater, 65201
- Missouri Cancer Associates
-
Columbia, Missouri, Forenede Stater, 65201
- Veterans Administration
-
Columbia, Missouri, Forenede Stater, 65212
- University of Missouri - Ellis Fischel,
-
Jefferson City, Missouri, Forenede Stater, 65101
- Capital Regional Medical Center
-
Saint Joseph, Missouri, Forenede Stater, 49085
- Lakeland Hospital
-
Saint Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine
-
Saint Louis, Missouri, Forenede Stater, 63131
- Missouri Baptist Cancer Center
-
Saint Louis, Missouri, Forenede Stater, 63131
- Missouri Baptist Medical Center
-
Saint Louis, Missouri, Forenede Stater, 63141
- Arch Medical Services, Incorporated at Center for Cancer Care and Research
-
Saint Louis, Missouri, Forenede Stater, 63141
- Center for Cancer Care and Research
-
Saint Louis, Missouri, Forenede Stater, 63141
- Comprehensive Cancer Care, PC
-
-
Nevada
-
Las Vegas, Nevada, Forenede Stater, 89102
- University Medical Center of Southern Nevada
-
Las Vegas, Nevada, Forenede Stater, 89106
- Nevada Cancer Research Foundation CCOP
-
Las Vegas, Nevada, Forenede Stater, 89106
- CCOP - Nevada Cancer Research Foundation
-
-
New Hampshire
-
Claremont, New Hampshire, Forenede Stater, 03743
- Valley Regional
-
Keene, New Hampshire, Forenede Stater, 03431
- Cheshire Medical Center-Dartmouth-Hitchcock Keene
-
Lancaster, New Hampshire, Forenede Stater, 03584
- Weeks Memorial Hospital
-
Lebanon, New Hampshire, Forenede Stater, 03756
- Dartmouth Hitchcock Medical Center
-
Lebanon, New Hampshire, Forenede Stater, 03766
- Alice Peck Day Memorial Hospital
-
Rochester, New Hampshire, Forenede Stater, 03867
- Frisbie Hospital
-
-
New Jersey
-
Camden, New Jersey, Forenede Stater, 08103
- Cooper Hospital University Medical Center
-
Livingston, New Jersey, Forenede Stater, 07039
- Saint Barnabas Medical Center
-
Voorhees, New Jersey, Forenede Stater, 08043
- Cancer Institute of New Jersey at Cooper - Voorhees
-
-
New York
-
Buffalo, New York, Forenede Stater, 14263
- Roswell Park Cancer Institute
-
East Syracuse, New York, Forenede Stater, 13057
- CCOP - Hematology-Oncology Associates of Central New York
-
Elmhurst, New York, Forenede Stater, 11373
- Elmhurst Hospital Center
-
Glens Falls, New York, Forenede Stater, 12801
- Glens Falls Hospital
-
Jamaica, New York, Forenede Stater, 11432
- Queens Hospital Center
-
New York, New York, Forenede Stater, 10065
- Memorial Sloan-Kettering Cancer Center
-
New York, New York, Forenede Stater, 10065
- Weill Medical College of Cornell University
-
New York, New York, Forenede Stater, 10029
- Mount Sinai Medical Center
-
Oswego, New York, Forenede Stater, 13126
- Oswego Hospital
-
Stony Brook, New York, Forenede Stater, 11794
- Stony Brook University Medical Center
-
Syracuse, New York, Forenede Stater, 13210
- Veterans Affairs Medical Center - Syracuse
-
Syracuse, New York, Forenede Stater, 13210
- State University of New York Upstate Medical University
-
Syracuse, New York, Forenede Stater, 13210
- SUNY Upstate Medical University Hospital
-
Syracuse, New York, Forenede Stater, 13210
- Syracuse Veterans Administration Medical Center
-
Syracuse, New York, Forenede Stater, 13203
- Saint Joseph's Hospital Health Center
-
Syracuse, New York, Forenede Stater, 13057
- Hematology Oncology Associates of Central New York-East Syracuse
-
-
North Carolina
-
Asheville, North Carolina, Forenede Stater, 28801
- Mission Hospital-Memorial Campus
-
Asheville, North Carolina, Forenede Stater, 28801
- Mission Hospital-Saint Joseph Campus
-
Chapel Hill, North Carolina, Forenede Stater, 27599
- University of North Carolina
-
Charlotte, North Carolina, Forenede Stater, 28204
- Novant Health Presbyterian Medical Center
-
Charlotte, North Carolina, Forenede Stater, 28203
- Carolinas Medical Center, Charlotte
-
Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical Center
-
Goldsboro, North Carolina, Forenede Stater, 27534
- Wayne Memorial Hospital, Incorporated
-
Kinston, North Carolina, Forenede Stater, 28501
- Kinston Medical Specialists
-
Kinston, North Carolina, Forenede Stater, 28501
- Lenoir Memorial Hospital
-
Wilson, North Carolina, Forenede Stater, 27893
- Wilson Medical Center
-
Winston-Salem, North Carolina, Forenede Stater, 27157-1096
- Wake Forest University Comprehensive Cancer Center
-
-
Ohio
-
Columbus, Ohio, Forenede Stater, 43210
- Ohio State University Comprehensive Cancer Center
-
Columbus, Ohio, Forenede Stater, 43210
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Forenede Stater, 15224
- West Penn Hospital
-
Pittsburgh, Pennsylvania, Forenede Stater, 15224-1791
- Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina
-
Easley, South Carolina, Forenede Stater, 29640
- Greenville Health System Cancer Institute-Easley
-
Greenville, South Carolina, Forenede Stater, 29601
- Saint Francis Hospital
-
Greenville, South Carolina, Forenede Stater, 29605
- Greenville Health System Cancer Institute-Andrews
-
Greenville, South Carolina, Forenede Stater, 29605
- Greenville Health System Cancer Institute-Faris
-
Greenville, South Carolina, Forenede Stater, 29605
- Greenville Memorial Hospital
-
Greenville, South Carolina, Forenede Stater, 29615
- Greenville Health System Cancer Institute-Eastside
-
Greenville, South Carolina, Forenede Stater, 29605
- Greenville Health System Cancer Institute-Butternut
-
Greenwood, South Carolina, Forenede Stater, 29646
- Self Regional Healthcare
-
Greer, South Carolina, Forenede Stater, 29650
- Cancer Centers of the Carolinas-Green Medial Oncology
-
Seneca, South Carolina, Forenede Stater, 29672
- Greenville Health System Cancer Institute-Seneca
-
Spartanburg, South Carolina, Forenede Stater, 29307
- Greenville Health System Cancer Institute-Spartanburg
-
-
Tennessee
-
Memphis, Tennessee, Forenede Stater, 38120
- Baptist Memorial Hospital and Cancer Center-Memphis
-
-
Vermont
-
Berlin, Vermont, Forenede Stater, 05602
- Central Vermont Medical Center/ National Life Cancer Treatment
-
Burlington, Vermont, Forenede Stater, 05405
- University of Vermont College of Medicine
-
Burlington, Vermont, Forenede Stater, 05401
- Fletcher Allen Health Care - University Health Center Campus
-
Newport, Vermont, Forenede Stater, 05855
- North Country Health
-
Saint Johnsbury, Vermont, Forenede Stater, 05819
- Northeastern
-
Springfield, Vermont, Forenede Stater, 05156
- Springfield Hospital
-
White River Junction, Vermont, Forenede Stater, 05009
- White River Junction Veteran Administration Medical Center
-
-
Virginia
-
Danville, Virginia, Forenede Stater, 24541
- Danville Regional Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inklusionskriterier:
- Klinisk diagnose af kronisk myelogen leukæmi (CML)
Samtidig tilmelding til en CALGB-behandlingsprotokol for nyligt diagnosticeret eller tidligere behandlet CML (f.eks. CLB-19804)
- Må ikke have påbegyndt studieterapi
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Gruppe 1
Perifere blodprøver og knoglemarvsaspirater opsamles ved baseline og 3, 6 og 9 måneder efter start af behandlingen. Hvis patienten fortsætter med at modtage protokolbehandling efter 9 måneder, udtages yderligere perifere blodprøver hver 6. måned, og knoglemarvsaspirater tages årligt. I tilfælde af sygdomsprogression (blastkrise) udtages en ekstra perifer blodprøve og knoglemarvsaspirat. Prøver undersøges ved kvantitativ Southern blot-analyse med prober til BCR, kvantitativ revers transkriptase-polymerase-kædereaktionsanalyse for BCR/ABL-fusionstranskripter og cytogenetisk analyse. |
Korrelative undersøgelser
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Fordelingssvar
Tidsramme: Op til 1,5 år
|
Op til 1,5 år
|
|
Fordeling af cytogenetisk respons
Tidsramme: Op til 1,5 år
|
Op til 1,5 år
|
|
Fordeling af RT-PCR-respons eller Southern blot-respons
Tidsramme: Op til 1,5 år
|
Op til 1,5 år
|
|
Hyppighed af resterende sygdom hos patienter, der har opnået et fuldstændigt respons
Tidsramme: Op til 12 måneder
|
Op til 12 måneder
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Wendy Stock, MD, University of Chicago
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Anslået)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CALGB-29801
- U10CA180821 (U.S. NIH-bevilling/kontrakt)
- U10CA031946 (U.S. NIH-bevilling/kontrakt)
- CDR0000078595 (Registry Identifier: NCI Physician Data Query)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med DNA-analyse
-
Centre Médico-Chirurgical de Réadaptation des Massues...RekrutteringIdiopatisk skolioseFrankrig
-
Charles University, Czech RepublicGeneral University Hospital, Prague; Czech Academy of Sciences; Czech Technical...RekrutteringInfertilitet | Infertilitet, kvinde | Infertilitet, Mand | Infertilitet UforklaretTjekkiet
-
Liao Jian AnRekrutteringHoved- og halskræftTaiwan
-
Nantes University HospitalIkke rekrutterer endnuRettsmedicinsk Tandlægevidenskab | Bidanalyse
-
Fondation LenvalTrukket tilbage
-
IRCCS Eugenio MedeaRekrutteringCerebral Parese | Erhvervet hjerneskadeItalien
-
IRCCS Eugenio MedeaAfsluttetAutismespektrumforstyrrelse | Tidlig indsatsItalien
-
Oregon Health and Science University4DMedicalTilmelding efter invitationLungesygdomme | KOL | Luftvejssygdom | DyspnøForenede Stater
-
Healthy.io Ltd.Afsluttet
-
Medwave Estudios LimitadaAsociación Chilena de SeguridadUkendtErhvervsmæssig eksponering | Muskuloskeletal sygdomChile